NCT07769424

Brief Summary

This proof-of-concept study will evaluate whether physiologic pacemaker programming improves cognitive function and health status in patients with symptomatic bradycardia who require permanent pacemaker implantation. Participants will be randomized to either standard pacemaker programming at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Cognitive function and health status will be assessed before pacemaker implantation and again at the routine 3-month pacemaker clinic visit. The primary outcome is change in Montreal Cognitive Assessment total score. The secondary outcome is change in SF-36 mental component summary score.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 11, 2026

Last Update Submit

August 17, 2026

Conditions

Symptomatic BradycardiaCognitive FunctionPacemakerHealth Status

Keywords

PACE CognitionSymptomatic bradycardiaPhysiologic pacingPacemaker programmingmyPACE algorithm

Outcome Measures

Primary Outcomes (1)

  • Change in Montreal Cognitive Assessment Total Score

    Change in Montreal Cognitive Assessment total score from baseline to 3 months after pacemaker implantation will be compared between participants randomized to standard pacemaker programming at 60 beats per minute and participants randomized to physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm. The Montreal Cognitive Assessment is scored from 0 to 30, with higher scores indicating better cognitive function.

    Baseline to 3 months after pacemaker implantation

Secondary Outcomes (1)

  • Change in Short Form 36 Health Survey Mental Component Summary Score

    Baseline to 3 months after pacemaker implantation

Study Arms (2)

Standard Pacemaker Programming

ACTIVE COMPARATOR

Participants randomized to this arm will receive standard pacemaker programming with a lower pacing rate of 60 beats per minute after permanent pacemaker implantation for bradycardia.

Device: Standard Pacemaker Programming

Physiologic Pacemaker Programming

EXPERIMENTAL

Participants randomized to this arm will receive individualized physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm after permanent pacemaker implantation for bradycardia.

Device: Physiologic Pacemaker Programming

Interventions

Physiologic Pacemaker ProgrammingDEVICE

Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.

Also known as: myPACE Algorithm
Physiologic Pacemaker Programming
Standard Pacemaker ProgrammingDEVICE

Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.

Standard Pacemaker Programming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patient requiring a pacemaker for bradycardia

You may not qualify if:

  • Vulnerable adult unable to give consent
  • Unable to answer questionnaire
  • Children
  • Pregnant women/persons
  • Prisoners
  • Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
  • Non-English speakers
  • Individuals unable to read
  • Employees or students of the researcher
  • Active members of the military or DoD personnel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, 55455, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Selma Carlson, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Markus Meyer, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Meyer, MD

CONTACT

802-922-0656markusmeyermd@gmail.com

Samantha Wansing

CONTACT

hoppx054@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants requiring permanent pacemaker implantation for bradycardia will be randomized to standard pacing at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Cognitive function and health status will be assessed before pacemaker implantation and at the routine 3-month pacemaker clinic visit.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 18, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

August 19, 2026

Record last verified: 2026-08

Locations

US(2)